FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
81337–81360 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 02, 2000
BIOCHECK TESTOSTERONE EIA, MODEL BC-1115
K002294 · CDZ
Biocheck, Inc.
Chemistry · 67d
Cleared Oct 02, 2000
CERALAS G15 532NM FREQUENCY DOUBLED ND:YAG LASER, MODEL G1-G15
K002296 · GEX
Ceram Optec, Inc.
General & Plastic Surgery · 66d
Cleared Oct 02, 2000
ENDIUS ENDOSCOPIC ACCESS SYSTEM
K002437 · HRX
Endius, Inc.
Orthopedic · 54d
Cleared Oct 02, 2000
STRYKER NAVIGATION SYSTEM - ENT MODULE
K002732 · HAW
Stryker Corp.
Neurology · 31d
Cleared Sep 29, 2000
OLYMPIC WARM-UP
K001056 · ILY
Olympic Medical Corp.
Physical Medicine · 179d
Cleared Sep 29, 2000
OMNIPORT
K002013 · GCJ
Advanced Surgical Concepts (Asc)
General & Plastic Surgery · 88d
Cleared Sep 29, 2000
BRAVO PH MONITORING SYSTEM
K002028 · FFT
Endonetics, Inc.
Gastroenterology & Urology · 88d
Cleared Sep 29, 2000
MODIFICATION TO: PRONTO DRY
K002451 · LYR
Medical Instruments Corporation, AG
Microbiology · 51d
Cleared Sep 29, 2000
MODIFICATION TO SYNTHES (USA) TROCHANTER STABILIZATION PLATE (TSB) FOR DHS...
K002710 · HRS
Synthes (Usa)
Orthopedic · 29d
Cleared Sep 29, 2000
BAYER IMMUNO 1 HER-2/NEU ASSAY
K992228 · NCW
Bayer Corp.
Immunology · 455d
Cleared Sep 29, 2000
BIOSYS FETAL MONITOR, MODEL IFM-500
K994008 · HGM
Biosys Co. , Ltd.
Obstetrics & Gynecology · 310d
Cleared Sep 29, 2000
MANUAL HER-2/NEU MICROTITER ELISA (OSDI HER-2/NEU ELISA)
K994112 · NCW
Oncogene Science, Inc.
Immunology · 298d
Cleared Sep 28, 2000
PREFERENCE TREATMENT SYSTEM
K001833 · IYE
Northwest Medical Physics Equipment,...
Radiology · 104d
Cleared Sep 28, 2000
MEDLINK DIAGNOSTIC OFFLINE WORKSTATION
K002144 · LLZ
Advanced Technology Laboratories, Inc.
Radiology · 73d
Cleared Sep 28, 2000
AUTOSTAT II ANTI-MYELOPEROXIDASE (MPO) ELISA
K002215 · MOB
Cogent Diagnotics , Ltd.
Immunology · 66d
Cleared Sep 28, 2000
COMFORT CONTROL SYRINGE SYSTEM
K002387 · EJI
Dentsply Intl.
Dental · 55d
Cleared Sep 28, 2000
3M RELY X VENEER CEMENT TRY-IN PASTER
K002452 · EMA
3M Company
Dental · 49d
Cleared Sep 28, 2000
HOLOGIC QDR X-RAY BONE DENSITOMETER/MODELS SERIES 4500, 4000, 2000, 1000 AND...
K002711 · KGI
Hologic, Inc.
Radiology · 28d
Cleared Sep 28, 2000
REBAR MICRO CATHETER: REBAR-10 (1.7F), 153 CM, DUAL MARKER BANDS
K002723 · KRA
Micro Therapeutics, Inc.
Cardiovascular · 28d
Cleared Sep 28, 2000
MODIFICATION TO PROFILE -II
K002776 · LCM
Medtox Diagnostics, Inc.
Toxicology · 22d
Cleared Sep 28, 2000
MODIFICATION TO PROVIDENT HIP SYSTEM
K002796 · LWJ
Stelkast Company
Orthopedic · 21d
Cleared Sep 28, 2000
MODIFICATION TO STANDARD IMAGING PT 1000 ION CHAMBER
K002833 · KPT
Standard Imaging, Inc.
Radiology · 16d
Cleared Sep 27, 2000
ORALUBE
K000847 · EFB
Orasystems
Dental · 196d
Cleared Sep 27, 2000
ASPECT MEDICAL SYSTEMS PEDIATRIC BIS EEG SENSOR, MODEL 186-0110
K001980 · GXY
Aspect Medical Systems, Inc.
Neurology · 90d